Speaker(s):

• Paul Heiden, Senior VP Corporate, Quality, Bayer AG
• Lou Schmukler, EVP & President, Global Product Development & Supply, Bristol-Meyers Squibb

Session Leader(s):

• Frances M. Zipp, President & CEO, Lachman Consultant Services

Speaker(s):

• Stephen M. Hahn, MD, Commissioner, FDA

Session Leader(s):

• Lou Schmukler, EVP & President, Global Product Development & Supply, Bristol-Meyers Squibb

Panelist(s):

• Brian Hasselbalch, Deputy Director, Office of Policy or Pharmaceutical Quality (OPPQ), FDA/CDER/OPQ
• Noreen Gleason, Director of Operations, Bristol Myers Squib
• Mike McDermott, President, Pfizer Global Supply
• Remo Colarusso, Vice President, Janssen Supply Chain, Janssen Supply Chain, LLC at Johnson & Johnson
• Theresa Rodó, Executive Vice President, Head of Global Healthcare Operations, Merck KGaA
• Joey Gouws, PhD, Team Lead, Inspection Services, Prequalification Team, World Health Organization

Session Leader(s):

• Frances M. Zipp, President & CEO, Lachman Consultant Services

Speaker(s):

• Katy George, Senior Partner, McKinsey & Company, Inc
• Pam Cheng, Executive VP of Global Operations & IT, Chief Sustainability Officer, AstraZeneca

Session Leader(s):

• Joseph Famulare, Conference Chair, VP Global Compliance & External Collaboration, Genentech, A Member of the Roche Group

Speaker(s):

• Tami J. Frederick, Senior Director, Corporate Quality Systems & Cultural Excellence, Perrigo
• Dr. Jennifer Maguire, PhD, Director of the Office of Quality Surveillance, CDER/FDA
• David Churchward, Global Head Sterility Assurance, Cell and Gene Technologies, Lonza Biologics

Session Leader(s):

• Jim Breen, VP Project Lead, Biologics Expansion, Janssen Pharmaceuticals

Speaker(s):

• Michel Lagarde, Executive Vice President, Thermo Fisher Scientific
• John Chiminski, Chair & CEO, Catalent Pharma Solutions

Speaker(s):

• Lou Schmukler, EVP & President, Global Product Development & Supply, Bristol-Meyers Squibb